Application 077066

Type: ANDA
Sponsor: SANDOZ

Related Records

Company: SANDOZ

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	CAPSULE;ORAL	75MG;25MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0185-0122	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Eon Labs, Inc.	ANDA	Current
0480-3470	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Teva Pharmaceuticals USA, Inc.	ANDA	Current
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Northstar RxLLC	ANDA	Current
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Northstar RxLLC	ANDA	Current
16714-439	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Northstar RxLLC	ANDA	Current
50090-3737	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	A-S Medication Solutions	ANDA	Current
50090-3737	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	A-S Medication Solutions	ANDA	Current
50090-3856	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	A-S Medication Solutions	ANDA	Current
53002-7041	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7041	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Quality Care Products, LLC	ANDA	Current
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Quality Care Products, LLC	ANDA	Current
55700-822	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Quality Care Products, LLC	ANDA	Current
60760-194	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
63187-995	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1459	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-1748	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
63629-7968	Nitrofurantoin	Nitrofurantoin (monohydrate/macrocrystals)	Bryant Ranch Prepack	ANDA	Current
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4367	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4428	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5076	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5076	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68084-446	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	American Health Packaging	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7092	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70518-1087	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	REMEDYREPACK INC.	ANDA	Current
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-269	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-546	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
71205-546	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Proficient Rx LP	ANDA	Current
72189-179	NITROFURANTOIN	NITROFURANTOIN	Directrx	ANDA	Current
72189-179	NITROFURANTOIN	NITROFURANTOIN	Directrx	ANDA	Current
72789-234	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-242	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-242	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-242	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76420-195	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Asclemed USA, Inc.	ANDA	Current
76420-195	Nitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin (monohydrate/macrocrystals)	Asclemed USA, Inc.	ANDA	Current